NCT06947460

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

CD19-BCMA CART Cell Therapy for Refractory Systemic Lupus Erythematosus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren Syndrome Combined With Pulmonary Artery Hypertension (pSS-PAH): a Single-center, Open, Non-randomized, Single-arm Clinical Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.

Conditions

• Refractory Lupus Nephritis
• Systemic Sclerosis
• Primary Sjogren's Syndrome Combined With Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	CD19-BCMA CAR-T cells infusion	Approximately 3-5 days prior to CD19-BCMA CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

Timeline

• Start date: 2025-04-18
• Primary completion: 2026-07-01
• Completion: 2026-07-31
• First posted: 2025-04-27
• Last updated: 2026-03-03

Locations

1 site across 1 country: China